Vaccines Europe Analysis of Vaccine Production Lead Times

Executive Summary

Background: Since technological developments and the response to the COVID-19 pandemic have the potential to impact vaccine manufacturing, this research was conducted on mRNA and viral vector–based COVID-19 vaccines in Q4 2022 using similar methods to a Vaccines Europe analysis of vaccine production lead times in 2015-18.

Results: Based upon interviews with industry subject matter experts, production lead times under pandemic-emergency conditions were estimated to be 3.5–6 months for viral vector and 2.5–5.5 months for mRNA-based COVID-19 vaccines. Differences between mRNA and viral vaccines were accounted for by the upstream manufacturing process (1.5–3 months for viral vector and ~1 month for mRNA-based vaccines), reflecting the time for cell culture, bioassay validation, and quality requirements for viral vector manufacturing.

Discussion/conclusions: The pandemic imposed variable effects on the supply of COVID-19 vaccines.

Factors accelerating time to market due to the pandemic included early investment in manufacturing and advanced agreements to support at-risk and/or in-parallel processes, prior to standard regulatory authorisations. Additional factors improving time to market included unprecedented collaboration and partnerships among vaccine manufacturers, regulators and control laboratories, simplified presentations, in-process inspection controls, and simplified administrative procedures and paperwork. Some of the factors accelerating production lead time during the pandemic could be adopted further and applied in a non-pandemic situation, such as further international harmonisation of regulatory processes, simplification of package requirements, and early dialogue between key stakeholders. Constraints inherent to vaccine manufacturing limit the ability to further accelerate production lead times, and the time needed to make vaccines available to end users does not principally depend on manufacturing. Steps excluded from this analysis include lengthy high-risk R&D, and quality assurance of materials and equipment; post-release testing; supply, shipment, and vaccine administration to end users. Accelerated lead times achieved during the pandemic were minimally impacted by production lead times and largely made possible by exceptional repurposing of preexisting technology platforms and unprecedented investment in research, development, and manufacturing scale-up. While new vaccine platforms and lessons from the pandemic have the potential to impact production lead times, sustained investment across vaccine types and technology platforms remains essential to address the challenges of communicable diseases, as no one platform is likely to be suitable for all pathogens.